T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057382
Recruitment Status : Terminated
First Posted : April 2, 2003
Last Update Posted : June 24, 2005
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Brief Summary:
This is an international, multicenter, randomized study of intravenous T138067 versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. A total of 750 subjects will be enrolled in this study.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: T138067 intravenous Drug: doxorubicin intravenous Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2003

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U.S. FDA Resources

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key inclusion criteria include:

  • pathologic diagnosis of unresectable HCC
  • chemotherapy-naïve for HCC
  • Child-Pugh Class A or B liver disease
  • measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI) or at least one lesion that is at least 10 mm on spiral CT scan
  • Karnofsky Performance Status of ≥ 70%
  • life expectancy of ≥ 12 weeks
  • adequate hematologic function (i.e., absolute neutrophil count [ANC] of ≥ 1500 cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dL)
  • total bilirubin of ≤ 1.5 upper limit of normal (ULN)
  • aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ULN
  • serum creatinine of ≤ 2 x ULN

Key exclusion criteria include:

  • severe, concurrent disease that would make the subject inappropriate for enrollment
  • Subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their HCC. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed)
  • history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
  • New York Heart Association (NYHA) class III or IV heart disease or a left ventricular ejection fraction of <50% or acute anginal symptoms
  • females who are pregnant or breast-feeding
  • received any investigational agent within 4 weeks of enrollment
  • history of central nervous system metastases or carcinomatous meningitis
  • clinically apparent ascites
  • major surgery within 4 weeks of study enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057382

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Sponsors and Collaborators
Study Director: Mohammad Hirmand, MD Tularik Identifier: NCT00057382     History of Changes
Obsolete Identifiers: NCT00066287
Other Study ID Numbers: T-067-010
First Posted: April 2, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: September 2004

Keywords provided by Tularik:
liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action